FDA.reportPublic FDA data

Theraderm Platinum Protection Facial Sunscreen SPF 40

Product NDC
66428-567
11-digit product format
664280567
Labeler code
66428
Product ID
66428-567_2740d21d-abbe-c2cc-e063-6294a90ace2c
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, OCTISALATE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Therapon Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-01
Substance
OCTOCRYLENE; OCTISALATE; ZINC OXIDE
Active strength
100; 50; 40 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Theraderm Platinum Protection Facial Sunscreen SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fea6ad8-4d33-4f7c-800c-1bee644bd97fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66428-567-00Theraderm Platinum Protection Facial Sunscreen SPF 401 in 1 BOXLOTION11
66428-567-00Theraderm Platinum Protection Facial Sunscreen SPF 4020 mL in 1 TUBELOTION201
66428-567-04Theraderm Platinum Protection Facial Sunscreen SPF 401 in 1 BOXLOTION11
66428-567-04Theraderm Platinum Protection Facial Sunscreen SPF 40118 mL in 1 TUBELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66428-567THERADERM PLATINUM PROTECTION FACIAL SUNSCREEN SPF 40 (OCTOCRYLENE, OCTISALATE, ZINC OXIDE) LOTION [THERAPON INC]1Current NDC, 4 package rows20241121_1fea6ad8-4d33-4f7c-800c-1bee644bd97f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 46 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e276e4-81f1-9429-e063-6394a90a800d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products106a9608-f7a4-0f8c-e063-6394a90a26ab2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fced72-39f9-f3a3-e063-6294a90a8b732026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc2a82-260c-7cd3-e063-6394a90af2c12026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd9aa5-dbd6-e5a7-e063-6394a90a3eac2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc93a7-f5be-965d-e063-6394a90ab3352026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd1661-1b91-b65b-e063-6394a90af89b2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Lipkist Lip Balm SPF 15LIP BALMArizona Sun Products11fbcb81-2735-53c8-e063-6394a90ab0fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd8776-99f8-e5a4-e063-6394a90a20332026-04-09WarningsExact identifier
application number: M020
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
application number: M020
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
application number: M020
Sunright 50AVOBENZONE, HOMOSALATE, AND OCTINOXATENSE Products, Inc.b1b76481-da23-427f-9b34-b987019fa5322026-04-09WarningsExact identifier
application number: M020
ThinkBaby SPF 30ZINC OXIDEthinkOperations,LLC06862b00-c937-41af-ab5d-cea34160d0352026-04-09WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.4a376e93-85e8-40a5-8641-d3e3d11fdeea2026-04-08WarningsExact identifier
application number: M020
AGE20S SUNSCREEN DUOZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAekyung Industrial Co., Ltd.4eef11cd-85a1-0e44-e063-6394a90a5d442026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66428-567-00664280567001 TUBE in 1 BOX (66428-567-00) / 20 mL in 1 TUBE1 tube2024-11-06NoNoCurrent
66428-567-04664280567041 TUBE in 1 BOX (66428-567-04) / 118 mL in 1 TUBE1 tube2024-11-01NoNoCurrent